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| Name | Class |
|---|---|
| Grand Pharmaceutical (China) Co., Ltd. | OTHER |
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To evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.
In this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. Azithromycin tear concentrations will be measured by LC-MS/MS at seven time points for 24 hours. Tolerability is evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| azithromycin eyedrop | Experimental | Each of the subjects' eyes will receive single dose of azithromycin eyedrops and then attribute the time for tear sampling at seven time points up to 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azithromycin eyedrop | Drug | Tear samples will be collected using the strips. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the maximum concentration (Cmax) | The tear samples are taken at 7 time points after administration up to 24 hours.The Cmax is calculated at the average concentration of each point. | The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours. |
| area under the curve (AUC) | The tear samples are taken at 7 time points after administration up to 24 hours.The AUC is calculated at the average concentration of each point. | The tear samples are taken at 7 time points after administration,including 10 minutes,half hour,2 hours,4 hours,8 hours,12 hours and 24hours. |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Ocular and systemic adverse events | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wu, Master | Contact | 010-58268486 | trdrug@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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